A Phase 1 Study of Single and Multiple Ascending Doses of GV-100
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGilva Therapeutics Inc.
About this trial
This is a first-in-human, multi-part clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), food effect, and drug-drug interaction (DDI) potential of GV-100 following oral administration in healthy participants. The study is divided into four parts: Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), Food Effect (FE), and Drug-Drug Interaction (DDI).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female participants, aged more than or equal 18 to less than or equal to 65 years at the time of providing informed consent, who are non-smokers (no use of tobacco or nicotine-containing products within 3 months prior to screening), with a body mass index (BMI) greater than 18.0 and less than 32.0 kilogram/meter square, and a minimum body weight of 50.0 kilogram.
No clinically significant illness or surgical procedures within 4 weeks prior to study drug administration.
No clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, or metabolic disorders.
Capable of understanding the study procedures and willing to provide written informed consent prior to participation.
Disqualifiers
Any clinically significant abnormal finding on physical examination, as determined by the Principal Investigator or delegate.
Clinically significant abnormal laboratory results at screening, in the opinion of the Principal Investigator or delegate.
Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and/or total bilirubin levels greater than 1.5 × the upper limit of normal (ULN) at screening.
Estimated glomerular filtration rate (eGFR) Less than or equal 90 milliliter/minute/1.73 meter square at screening, calculated using the CKD-EPI equation.
Trial design
Design model
Sequential
Treatments tested in this trial
GV-100
DrugGV-100 will be administered orally
Placebo
DrugMatched to GV-100
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: GV-100Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Adverse event
Time frame
Up to 7 weeksSecondary outcomes
1
Maximum plasma concentration (Cmax) of GV-100
Plasma concentration of GV-100
Time frame
Part 1: From Day 1 to Day 2 Part 2: From Day 1 to Day 15 Part 3: From Day 1 to Day 9 Part 4: From Day 1 to Day 152
Area under the plasma concentration time curve (AUC) of GV-100
Measure of AUC
Time frame
Part 1: From Day 1 to Day 2 Part 2: From Day 1 to Day 15 Part 3: From Day 1 to Day 9 Part 4: From Day 1 to Day 15Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov